At the time of initial PAAB review for the brochure, we should be informed of all items that will be distributed along with the piece. It’s not just about the explicit messaging but also how the item may take on a meaning in the context of the brochure or how the item may inherently add meaning to the brochure.
- e.g. Say product X is contraindicated in diabetes but the patient kit contains a pair of the leading brand of diabetics socks.
- e.g. Product Y does not have any acceptable data pertaining to activities and exercise tolerance. The originally submitted piece had plenty of images of people skiing, mountain climbing, mountain biking, performing slam dunks… and PAAB required these to be removed. But the HCP kit contains cut outs of a ski mask image, a paper basketball, a miniature ski pole…etc.
In both examples above, the linkage of the ancillary items to the PAAB approved piece contravenes the code (even though the items themselves do not contain a single word). In short, if we are approving a piece, we need to know what context it will be used in (and this includes knowing what items will appear with it). In cases where the other items do not carry text and would be otherwise exempt as separate items, they can be reviewed as part of the submission for the brochure or box kit (rather than separate dockets).